Onvansertib

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 18, 2024 /PRNewswire/ -- USA News Group News Commentary – The American Cancer Society recently released its Advances in Oncology – 2024 Research Highlights report that highlighted how their scientists continued to set the standard for research and innovation over the course of the year. However, along with the report's optimism, the American Cancer Society also recently released a study finding that early-onset colorectal cancer cases are surging globally, signaling an alarming trend. A new article published in Nature showed that the COVID-19 pandemic severely disrupted cancer care, causing delays in diagnosis, treatment, and screening services, which likely led to more advanced disease stages, poorer survival outcomes, and significant challenges in accurately interpreting long-term cancer survival data. In the world of oncology, there are still several challenges that need to be addressed and new treatments to be rolled out, but thankfully, there have been several recent developments coming out from innovators, including O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cardiff Oncology, Inc. (NASDAQ: CRDF), OS Therapies, Inc. (NYSE-American: OSTX), Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), and Eli Lilly and Company (Lilly) (NYSE: LLY). The article continued: Not long ago, the American Cancer Society sounded the alarm on a surging rise in cancer diagnoses and fatalities among younger. For the industry targeting the alarming issue, analysts at Exactitude Consultancy project the Cancer Immunotherapy Market to expand at a 12.84% CAGR, reaching $258.22 billion by the end of 2031, further solidifying oncology as a dynamic and evolving sector. Oncolytics Biotech® to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the presentation of two data sets through two abstracts showcasing pelareorep's potential in difficult-to-treat gastrointestinal cancers, which were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. "We are enthusiastic about pelareorep's applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer," said Tom Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Pelareorep engages patients' immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devasting diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients." Oncolytics will present two key data sets from the GOBLET study, with preliminary safety and tumor response results for the relapsed anal carcinoma cohort treated with pelareorep and atezolizumab presented in Poster Session C on January 25, 2025, from 7:00 to 7:55 a.m. PT. Additionally, results from the safety run-in phase for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, with and without atezolizumab will be presented in Poster Session B on January 24, 2025, from 11:30 a.m. to 1:00 p.m. PT. Both abstracts will be available on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy and safety data are for all evaluable patients as of a November 26, 2024, data cut-off date, and all efficacy data are determined by a blinded, independent central review (BICR) of each patient's tumor scan. "We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial," said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. "Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses." OS Therapies, Inc. (NYSE-American: OSTX), a clinical-stage cancer immunotherapy and antibody-drug conjugate biotechnology company, recently reported its Q3 2024 financial results for the quarter and provided a business update. Within the quarter, OS Therapies completed dosing all patients in its potentially pivotal Phase 2b clinical trial of OST-HER2 for resected, recurrent osteosarcoma and is preparing to release topline data in December. The company also joined Johnson & Johnson's JLABS program, completed its IPO on the NYSE American, and is in active discussions with the FDA regarding Breakthrough Therapy Designation for OST-HER2. "The third quarter was pivotal for OS Therapies as we completed our initial public offering and finished dosing the final patient enrolled in our Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma," said Paul Romness, MHP, Chairman and CEO of OS Therapies. "We are now looking forward to releasing topline data in December and then engaging with the FDA regarding getting this potentially life-saving cancer immunotherapy to patients that have no other potential treatment options as quickly as possible." Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), a commercial-stage immunotherapy and targeted oncology company focused on novel treatments for patients with solid tumor cancers, recently announced that the FDA approved its UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication. "[This] FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC," said James Oliviero, President and CEO of Checkpoint. "This approval marks Checkpoint's transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (PD-1), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC." Eli Lilly and Company (Lilly) (NYSE: LLY), a medicine company turning science into healing to make life better for people around the world, recently announced results from its Phase 3 BRUIN CLL-321 trial, which tested pirtobrutinib, a next-generation treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had previously been treated with a similar type of drug. The study showed that pirtobrutinib significantly reduced the risk of disease progression or death by 46% compared to standard treatments (idelalisib plus rituximab or bendamustine plus rituximab). These promising results were presented at the 66th American Society of Hematology (ASH) Annual Meeting. "BRUIN CLL-321 is the only randomized CLL or SLL study ever conducted exclusively in the BTK-inhibitor pre-treated population, where there is significant need for new treatment options, and these data illustrate pirtobrutinib's ability to meaningfully delay disease progression and time to next treatment in this setting," said David Hyman, M.D., Chief Medical Officer of Lilly. "This is the first in our suite of randomized Phase 3 trials for pirtobrutinib to readout and we look forward to continuing to build the body of evidence supporting the role of pirtobrutinib in advancing care for people with B-cell malignancies." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

- Initial results from randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care in RAS-mut mCRC demonstrated 64% ORR in the 30mg onvansertib dose arm versus 33% ORR in the control arm - - In the experimental arms, 30mg dose of onvansertib demonstrated a higher ORR compared to 20mg dose of onvansertib (64% vs. 50%) with deeper tumor regression in the 30mg arm - - Onvansertib was well tolerated at both doses - - Additional clinical data from CRDF-004 trial expected in 1H 2025 - - Company will hold a conference call today at 8:00 a.m. ET / 5:00 a.m. PT - Dec. 10, 2024 -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy and safety data are for all evaluable patients as of a November 26, 2024 data cut-off date, and all efficacy data are determined by a blinded, independent central review (BICR) of each patient’s tumor scan. “We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses.” The CRDF-004 phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients are being randomized in a 1:1:1 ratio to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety. Objective Response Rates observed in the CRDF-004 clinical trial, as of the data cut-off date of November 26, 2024, are shown below. Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses observed in patients receiving the 30mg dose of onvansertib in combination with the SoC compared to both the control arms and 20mg dose of onvansertib arms. Note: Radiographic response determined per RECIST 1.1 by blinded independent central review. Spider plot reflects interim data as of November 26, 2024 from an ongoing trial and unlocked database. Additional clinical data from CRDF-004 trial expected in 1H 2025 Cardiff Oncology will host a conference call and live webcast at 8:00 a.m. ET / 5:00 a.m. PT on December 10, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Events" section of the company's website. A webcast replay will be available in the investor relations section on the company's website following the completion of the call. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to SoC alone. For more information, please visit https://www.cardiffoncology.com. The content above comes from the network. if any infringement, please contact us to modify.